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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001-02-09 to 2001-03-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
02-1987
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone
EC Number:
604-593-2
Cas Number:
147622-85-3
Molecular formula:
C18 H22 F2 O
IUPAC Name:
4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:KBL
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Kisslegg, Germany
- Age at study initiation: 19 weeks
- Weight at study initiation: 3.23 - 3.44 kg
- Housing: separately in Becker type K99/30 KU cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 45 - 48
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: Days 1 to 8

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Single application into the conjunctival sac of the left eye, the right eye remained untreated and served as control.
Observation period (in vivo):
1 hour after treatment and then daily for a period of further 7 days
Number of animals or in vitro replicates:
3 f
Details on study design:
In a pretest (HET-CAM) the test item revealed no irritating potential. Nevertheless the primary irritation study was started with three rabbits.
24 hours before treatment ophthalmological examinations were performed after instillation of 0.15 % fluorescein solution using an ophthalmoscope. After instillation of the test item the eyelids were closed for about 30 seconds. Rinsing of the eyes was not performed.
The rabbits were investigated for eye irritation and for changes in behaviour and general condition 1 hour after treatment and then daily for a period of further 7 days.
All rabbits were weighed before the start of the study and on days 5 and 8.
Local changes of the eye were evaluated according to the recommendations of the OECD.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0.33
Reversibility:
fully reversible within: 2 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed at the cornea and iris. The conjunctivae showed redness (scores 1 and 2) on days 1 and 2 of the study. Otherwise chemosis (score 1) was seen in one animal at the first reading. Later on no signs of irritation were observed. The untreated eyes were unchanged.

Any other information on results incl. tables

Study design

For the test of primary eye irritation, 100 mg of the test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The examinations were performed daily for further 7 days.

Results

No signs of irritation were observed at the cornea and iris. The conjunctivae showed redness (scores 1 and 2) on days 1 and 2 of the study. Otherwise chemosis (score 1) was seen in one animal at the first reading. Later on no signs of irritation were observed. The untreated eyes were unchanged.

Conclusion

The test item revealed a very weak irritating potential in this study and has not to be regarded as an irritant for the eyes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the results of this study the test material is regarded as non-irritant for the eyes.
Executive summary:

This GLP study was performed according to OECD GL 405. According to the results of this study the test material is regarded as non-irritant for the eyes.